Indian Arm Of Pharma Major Gets USFDA Approval To Market Birth Control Pill

Lupin has received final approval from the US health regulator for marketing Norgestimate and Ethinyl Estradiol tablets in the US market.

Highlights

Pharma Major Lupin Ltd said it received final approval from USFDA to market Norgestimate and Ethinyl Estradiol Tablets.
Norgestimate and Ethinyl Estradiol Tablets are used as contraception to prevent pregnancy.
The approved product will be manufactured at Lupin’s Pithampur facility.

Pharma Major Lupin Ltd said it received final approval from the United States Food and Drug Administration (USFDA) to market Norgestimate and Ethinyl Estradiol Tablets in the United States of America.

Lupin is an innovation-led transnational pharmaceutical company developing and delivering a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally. Lupin Pharmaceuticals Inc is headquartered in Baltimore, Maryland.

Birth Control Pills | Contraceptive Pills Types Advantages Side Effects & Risks
Oral contraceptive or birth control pills contain hormones that prevent pregnancy. It is one of the most reliable methods of contraception.

‘The pills work by changing the cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.’

"We have received final approval for norgestimate and ethinyl estradiol tablets USP, 0.25 mg/0.035 mg, from the United States Food and Drug Administration (FDA) to market a generic version of Janssen Pharmaceuticals Ortho-Cyclen 28 tablets," a company statement said today.

Norgestimate and Ethinyl Estradiol Tablets are AB rated generic equivalent of Janssen Pharmaceuticals Inc.’s Ortho-Cyclen 28 Tablets .

Norgestimate and Ethinyl Estradiol Tablets are used as contraception to prevent pregnancy.

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Acne is a common skin condition that usually affects adolescents. Birth control pills can be used to treat severe acne in women.

It causes changes in cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

The approved product will be manufactured at Lupin’s Pithampur facility.

Popping Those Birth Control Pills can Put You at an Increased Stroke Risk
Oral contraceptives increase the risk of ischemic strokes, which are caused by blood clots and account for about 85% of all strokes.

Ortho-Cyclen Tablets had US sales of $178.2 million according to IMS MAT for June 2016.

The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, etc.

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Drug companies, including Bristol-Myers Squibb (BMS), have created some experimental male contraceptives, but these too have drawbacks.

Lupin is the 5th largest pharmaceutical company in the US by prescriptions (4.68% market share, according to IMS Health, National Prescription Audit, March 2016).

For the financial year ended 31st March, 2016, Lupin’s Consolidated sales and Net profit stood at Rs 136,539 mln ($ 2.09 billion) and Rs 22,607 mln ($ 345 million) respectively.

Source-Medindia